Piperacillin / Tazobactam

Brands of Piperacillin / Tazobactam in Kenya

Apotaz-P, Apoorv Nutra Pharm PVT Ltd

Aurotaz-P, Aurobindo Pharma Limited

Inno-Zopip, Innocia Lifesciences Pvt. Ltd.

Injpip, Inject Care Parenterals Pvt.Ltd

Pezonep, Inject Care Parenterals Pvt.Ltd

Piptaz, Zawadi Healthcare Ltd

Piptazo, Sandoz GmbH Kundl

Pipzo, Alkem Laboratories

Pizomark, Marksans Pharma Limited

Tazact, Cipla

Tazilsun, Zhuai

Tazocin EF, Pfizer Laboratories Limited


Piperacillin/Tazobactam in Kenya
Piperacillin-Tazobactam Vial

MODE OF ACTION

Tazobactam inhibits beta lactamase and prevents the destruction of piperacillin. Therefore, tazobactam is given with piperacillin to enhance the activity of piperacillin in eradicating bacterial infections. Piperacillin kills bacteria by inhibiting the synthesis of bacterial cell walls.

INDICATIONS

Adults and adolescents

Severe pneumonia including hospital-acquired and ventilator-associated pneumonia

Complicated urinary tract infections (including pyelonephritis)

Complicated intra-abdominal infections

Complicated skin and soft tissue infections (including diabetic foot infections)

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed above.

Piperacillin/Tazobactam may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.

Children aged 2-12 years

Complicated intra-abdominal infections

Piperacillin/Tazobactam may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection.

Consideration should be given to official guidance on the appropriate use of anti-bacterial agents.

DOSAGE AND ADMINISTRATION

Adult Patients

The usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 grams every six hours totaling 13.5 grams (12 grams piperacillin/1.5 grams tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.

Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

Nosocomial Pneumonia

Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 grams every six hours plus an aminoglycoside, totaling 18 grams (16 grams piperacillin/2 grams tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

Renal Impairment

In patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows

Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal-Impairment (As total grams piperacillin/tazobactam)

* Creatinine clearance for patients not receiving hemodialysis

** 0.75 gram (0.67 gram piperacillin/0.08 gram tazobactam) should be administered following each hemodialysis session on hemodialysis days

Renal Function
(creatinine clearance, mL/min)
All Indications
(except nosocomial pneumonia)
Nosocomial
Pneumonia
>40 mL/min3.375 q 6 h4.5 q 6 h
20 to 40 mL/min*2.25 q 6 h3.375 q 6 h
<20 mL/min*2.25 q 8 h2.25 q 6 h
Hemodialysis**2.25 q 12 h2.25 q 8 h
CAPD2.25 q 12 h2.25 q 8 h

CONTRAINDICATIONS

Hypersensitivity to the active substances or any other penicillin-antibacterial agent .

History of acute severe allergic reaction to any other beta-lactam active substances (e.g. cephalosporin, monobactam or carbapenem).

DRUG INTERACTIONS

Non-depolarising muscle relaxants

Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Due to their similar mechanisms of action, it is expected that the neuromuscular blockade produced by any of the non-depolarising muscle relaxants could be prolonged in the presence of piperacillin.

Oral anticoagulants

During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.

Methotrexate

Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.

Probenecid

As with other penicillins, concurrent administration of probenecid and piperacillin/tazobactam produces a longer half-life and lower renal clearance of piperacillin and tazobactam; however peak plasma concentrations of either active substance are unaffected.

Aminoglycosides

Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.

The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.

Vancomycin

No pharmacokinetic interactions have been noted between piperacillin/ tazobactam and vancomycin.

Effects on laboratory tests

Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins. Therefore, enzymatic urinary glucose measurement is required under piperacillin / tazobactam therapy.

A number of chemical urine protein measurement methods may lead to false-positive results. Protein measurement with dip sticks is not affected.

The direct Coombs test may be positive.

Bio-Rad Laboratories Platelia Aspergillus EIA tests may lead to false-positive results for patients receiving piperacillin / tazobactam. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported.

Positive test results for the assays listed above in patients receiving piperacillin / tazobactam should be confirmed by other diagnostic methods.

ADVERSE EFFECTS

Gastrointestinal—hepatitis, jaundice

Hematologic—hemolytic anemia, agranulocytosis, pancytopenia

Immune—hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock)

Renal—interstitial nephritis

Skin and Appendages—erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:


Piperacillin / Tazobactam in Kenya
Piperacillin / Tazobactam in Kenya
Piperacillin / Tazobactam in Kenya
Piperacillin / Tazobactam in Kenya
Piperacillin / Tazobactam in Kenya
Piperacillin / Tazobactam in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: Intravenous infusion
Bioavailability: Not Available
Protein Binding: Not Available
Metabolosim: Not Available
Onset of Action: N/A
Elimination Half life: Not Available
Excretion: Not Available

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


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